The device is intended to be used as a tool in displaying and viewing digital images, including digital mammography system for view and analyses by trained medical practitioner.

Device Description

The MMD-5201M LCD monitors are displays for medical use. MMD-5210M provides 5 mega pixel resolution and 766 grayscales per pixel display. The display device is complied with the standard ISO13406-2 to conform to the requirement of the mammography display system.

AI/ML Overview

The provided text describes a 510(k) summary for the PACSmate MMD-5201M monitor. This document focuses on the regulatory clearance of a medical display device, not an AI or diagnostic algorithm, therefore, many of the requested criteria related to AI/algorithm performance and clinical studies are not applicable.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a numerical table form for performance. Instead, it indicates compliance with standards and equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Displaying and viewing digital images, including digital mammography for analysis by trained medical practitioners.	The performance test results demonstrated that the device meets its intended use specifications as a displayer for medical images.
Resolution	5 Megapixel (up to 2560 x 2048 pixels)
Grayscales per pixel	766 grayscales per pixel
Brightness	Maximum 850 cd/m2
Contrast Ratio	600:1
Compliance with ISO 13406-2 standard (ergonomic requirements for flat panel displays)	The display device is complied with the standard ISO13406-2 to conform to the requirement of the mammography display system. The technical specification is compliance with the ISO 13406-2 standard: ergonomic requirements for flat panel displays ergonomics.
Substantial Equivalence to Predicate Device (EIZO RadiForce GS520)	Claimed to be substantially equivalent in terms of intended use, construction, function, safety, operating environmental conditions, and effectiveness. MMD-5201M employs the maximum resolution values same as that of RadiForce GS520. Performance testing demonstrated the device meets its intended use specifications and requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance testing "demonstrated that the device meets its intended use specifications," but details about the methodology, sample size of images or cases tested, or data provenance are absent. As this is a display monitor, the "test set" would likely refer to images displayed on the monitor, but no specifics are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is largely not applicable for a medical display device. The device itself is not making a diagnostic judgment, so there is no "ground truth" in the sense of expert consensus on disease presence/absence to be established for the display's own performance. The document states the device is for "viewing and analyses by trained medical practitioner," implying the target user, but not for defining ground truth for the display's testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable for a medical display device. Adjudication methods are typically used in studies where human readers are interpreting images and their agreement is being assessed against a ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was done. This type of study is relevant for AI or CAD (Computer-Aided Detection/Diagnosis) systems, not for a passive display monitor. The device itself is a display, not an AI or CAD tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a display monitor, not an algorithm. Its function is to render images for human interpretation, not to provide an automated diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable for a medical display monitor in the context of its performance validation. The "ground truth" for a display would refer to the fidelity of the image presentation, adherence to display standards, and visual quality, not diagnostic accuracy based on pathology or outcomes.

8. The sample size for the training set

This is not applicable. The PACSmate MMD-5201M monitor is a hardware device. It does not utilize a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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K101796

510(k) Summary

[As required by section 807.92(c)]

1. Submitter: IEI Technology Corp. No.29 Jhong-Sing Road, Si-Jhih City, Taipei Country 221, Taiwan, (R.O.C.) TEL: +886-2-26902098 EXT: 18853 FAX: +886-2-26902099 EXT: 18853
1. Official Correspondent: Tom Chen (Mr.)

ງປະ 1 ຮູ້ 2010

1. Date of 510(k) Submittal: 6. January, 2010
1. Device Trade Name PACSmate MMD-5201M monitor
1. Common Name: LCD monitor
1. Classification Name: System, image processing, radiological [were classified in class II (21 CFR 892.2050)]
1. Device Product Code: LLZ
1. Predicate Device:

Manufacturer: EIZO NANAO CORPORATION Device name: 5 Megapixel monochrome LCD monitor Model name: RadiForce GS520 510(k) No.: K080422

Device Description:

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10.Intended Use:

The device is intended to be used as a tool in displaying and viewing digital images, including digital mammography system for view and analyses by trained medical practitioner.

11. Technological Characteristics:

The PACSmate MMD-5201M is a high performance, 5 Megapixel medical grade monochrome LCD monitors designed for exacting needs for diagnostics professionals that provide clear and sharp images with resolutions of up to 2560 x 2048 pixels, up to maximum 850 cd/m2 brightness and 600:1 contrast ratio, making it ideal for diagnosing detailed medical graphics. Also uses a DVI digital interface offering compatibility with the latest digital standards. The technical specification is compliance with the ISO 13406-2 standard: ergonomic requirements for flat panel displays ergonomics.

12.Performance Testing:

The performance test results for the PACSmate LCD monitor demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a displayer for medical image.

13. Substantial Equivalence to Predicate Device:

PACSmate MMD-5201M is substantially equivalent to RadiForce GS520. MMD-5201M employs the maximum resolution values same as that of RadiForce GS520. Comparison table of the principal characteristics of two devices is shown in the Section II and specification data for the use of mammography system monitor is included in Section I.

14.Conclusion:

In terms of intended use, construction, function, safety, operating environmental conditions, and effectiveness of the PACSmate MMD-5201M monitor is substantially equivalent to the predicate device used for this application.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

IEI Technology Corporation % Mr. Marc M. Mouser Manager & FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

JUL 1 5 2010

Re: · K101796

Trade/Device Name: PACSmate MMD-5201M monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 17, 2010 Received: June 28, 2010

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Not known

K101796

Device Name: PACSmate MMD-5201M monitor

Indications for Use:

The device is intended to be used as a tool in displaying and viewing digital images, including digital mammography system for view and analyses by trained medical practitioner.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

D'thn

(Division Sign-Off). Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K101796

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).